Regulatory Affairs Manager

vor 4 Wochen

Kloten, Schweiz Nobel Biocare Vollzeit

Operating Company: Nobel Biocare
Location: Kloten,Zurich,CH
Date Posted: February 19, 2024
Req Number: R5018921
- Lead development and execution of regulatory strategies for Prosthetics & Digital development projects for market access to EU/UK/CH, US & CA, compliance projects and lifecycle management activities and ensure all RA related elements & requirements are implemented.
- Assembling, and ensuring quality of the deliverables related to CE/UKCA marking, 510(k) submissions and Health Canada submissions for Prosthetics & Digital devices and workflows.
- Represent the RA function in software integration or digital workflow implementation projects for market access to EU/UK/CH, US & CA.
- Provide regulatory input and technical guidance on respective regulatory requirements to project teams.
- Revise or create Technical Files and review to ensure they are in compliance with procedures and consistent and that the input documents fulfill regulatory requirements.
- Evaluate the regulatory environment and contribute by providing advice throughout the product lifecycle to ensure product compliance.
- Evaluate proposed change requests and drive the regulatory implementation of change requests.
- Provide regulatory information and guidance for proposed product claims/labeling. Ensure clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims.
- Review of labels and IFUs.
- Support internal and external audits through audit preparation, audit back-office or in audit front office. Proactively plan and organize audits and ensuring audit team and SMEs are appropriately trained.
- Creation and maintenance of regulatory procedures and templates. Identification of updates required for compliance, correctness, interaction or efficiency reasons, as well as need for any new procedures.

LI-EU1

**Job Requirements**:
**Critical Knowledge and Qualifications**:

- A minimum of a Bachelor’s degree from accredited college or university is required. A Master’s degree or PhD is of advantage. A degree focused in technology or science is preferred.
- In depth knowledge of core aspects of the medical device quality management systems 21 CFR Part 820, ISO 13485 and MDSAP.
- In depth knowledge of core aspects of the MDR including classification, technical file requirements and GSPRCs. Overview knowledge on remaining areas including country specific requirements.
- In depth knowledge of core aspects of US and CA regulatory system set-ups, classification methods and submission principles.
- Knowledge of core aspects of the design control process requirements and requirements for technical documentation for medical devices.

**Critical Skills/technical know-how**:

- Fluency in English a must. German or further languages is an advantage.
- Able to communicate effectively with stakeholders, ensure understanding, alignment on issues questions and goals.
- Able to work in teams and to build up a multidisciplinary network. Contribute to building a respectful, diverse and inclusive workplace, where decisions and transactions are transparent and fair.
- Able to support decision making process and establish basis for selection of solutions.
- Capable to plan out daily work to deliver on time, able to make adjustments when required and prioritizing work.

**Critical Experience**:

- Minimum 4-5 years' experience in regulatory affairs within medical device industry.
- Minimum 3 years' experience in working directly with authorities.

**Operating Company**:
Nobel Biocare

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